Back to resultsA Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
Primary Purpose
Carcinoma, Hepatocellular
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
RT
TACE
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular
Eligibility Criteria
Inclusion Criteria:
- confirmed by pathology or met the clinical diagnostic criteria of hepatocellular carcinoma.
- after the joint consultation between the interventional department and the radiotherapy department, the patients who were considered to be interventional were considered. Meeting the following criteria: the tumor was confined to the liver (meeting the liver tolerance dose), and was diagnosed as type II or type III portal vein tumor thrombi according to chang's classification criteria, without extrahepatic metastasis. Number of tumors in liver parenchyma: less than or equal to 3. The main portal vein is not completely blocked or the compensatory collateral vessels of the portal vein are abundant although it is completely blocked.
- patients who meet all the following criteria: Child-Pugh score ≤7, PLT>30×109/L, WBC>3×10^9/L/ANC>1.5×10^9/L,Hb>90g/L, Cr<2.0mg/dL.
- ECOG score 0-2 points.
- estimated survival time > 3 months.
- age > 18.
- sign the informed consent.
Exclusion Criteria:
- patients with the following condition: the number of intrahepatic tumors >3 or total tumor diameter>15cm.
- patients with signs of extrahepatic metastasis, including but not limited to inferior vena cava carcinoma thrombus, bone metastasis, brain metastasis or regional lymph node metastasis.
- patients with West Haven standard grade III/IV hepatic encephalopathy or ascites.
- patients with a history of malignancy other than primary HCC, except for cutaneous squamous cell carcinoma or basal cell carcinoma.
- patients with a history of upper abdominal radiotherapy.
- in the radiotherapy plan, patients who failed to follow the radiation dose limit of important organs, including those whose normal liver tissue was less than 700 ml in the radiotherapy plan.
- screening patients who have received other study drugs within 4 weeks prior to the start of the visit.
- screening: patients who had received treatment for other local or systemic hepatocellular carcinoma within 4 weeks before the visit.
- patients with significant concurrent diseases.
- lactating or pregnant female patients.
Sites / Locations
- Zhongshan HosptialRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TACE
TACE+RT
Arm Description
Outcomes
Primary Outcome Measures
OS
overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT03939845
First Posted
April 23, 2019
Last Updated
May 4, 2019
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03939845
Brief Title
A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
Official Title
A Prospective, Randomized, Multicenter Study of Comparison of Transarterial Chemoembolization (TACE) Combination With and Without External- Beam Radiotherapy (EBRT) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
April 23, 2021 (Anticipated)
Study Completion Date
April 23, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The 1-year and 2-year overall survival rate (OS), local control rate (FFLP), disease-free progression time (PFS), and side effects were compared in patients with hepatocellular carcinoma limited to intrahepatic unresectable hepatocellular carcinoma with portal venous thrombosis combined with or without external radiotherapy, providing a basis for the development of relevant guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE
Arm Type
Active Comparator
Arm Title
TACE+RT
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
RT
Intervention Description
external- beam radiotherapy (EBRT)
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
transarterial chemoembolization (TACE)
Primary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed by pathology or met the clinical diagnostic criteria of hepatocellular carcinoma.
after the joint consultation between the interventional department and the radiotherapy department, the patients who were considered to be interventional were considered. Meeting the following criteria: the tumor was confined to the liver (meeting the liver tolerance dose), and was diagnosed as type II or type III portal vein tumor thrombi according to chang's classification criteria, without extrahepatic metastasis. Number of tumors in liver parenchyma: less than or equal to 3. The main portal vein is not completely blocked or the compensatory collateral vessels of the portal vein are abundant although it is completely blocked.
patients who meet all the following criteria: Child-Pugh score ≤7, PLT>30×109/L, WBC>3×10^9/L/ANC>1.5×10^9/L,Hb>90g/L, Cr<2.0mg/dL.
ECOG score 0-2 points.
estimated survival time > 3 months.
age > 18.
sign the informed consent.
Exclusion Criteria:
patients with the following condition: the number of intrahepatic tumors >3 or total tumor diameter>15cm.
patients with signs of extrahepatic metastasis, including but not limited to inferior vena cava carcinoma thrombus, bone metastasis, brain metastasis or regional lymph node metastasis.
patients with West Haven standard grade III/IV hepatic encephalopathy or ascites.
patients with a history of malignancy other than primary HCC, except for cutaneous squamous cell carcinoma or basal cell carcinoma.
patients with a history of upper abdominal radiotherapy.
in the radiotherapy plan, patients who failed to follow the radiation dose limit of important organs, including those whose normal liver tissue was less than 700 ml in the radiotherapy plan.
screening patients who have received other study drugs within 4 weeks prior to the start of the visit.
screening: patients who had received treatment for other local or systemic hepatocellular carcinoma within 4 weeks before the visit.
patients with significant concurrent diseases.
lactating or pregnant female patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jiazhou hou, doctor
Phone
+86-021-64041990
Ext
2764
Email
hou.jiazhou@zs-hosptial.sh.cn
Facility Information:
Facility Name
Zhongshan Hosptial
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiazhou hou
Phone
+8602164041990
Ext
+8602164041990
Email
hou.jiazhou@zs-hosptial.sh.cn
12. IPD Sharing Statement
Learn more about this trial
A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
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